The aim of this study is to investigate the effect of cold application and Inhalation of Lavender Essential Oil on pain and anxiety during Chest tube removal (CTR). Design of this study is randomized, clinical trial with a factorial design. Pain intensity in five stages (before, immediately, 5, 10 and 15 minutes after CTR), pain quality and anxiety in two stages (before and immediately after CTR) were measured. Sample 80 patients who are undergoing cardiac surgery in cardiac surgery intensive care unit of Imam Reza hospital at Mashhad. Verbal and written informed consent is obtained from each of the patients for the present study. The patients were assigned to four randomized groups that included cold application, aromatherapy with inhalation of lavender essential oil, cold application in combination of inhalation of lavender essential oil and control groups.
For cold was used from cold gel packs manufacturing Dispotch Italy company and for aromatherapy was used from essential oils made in GIAH essence pharmaceutical company (Gorgan - Iran) after analyzed by gas chromatography.
General information
Acronym
cardiac chest tube removal or CRT
IRCT registration information
IRCT registration number:IRCT2015080523515N1
Registration date:2015-09-05, 1394/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Narges Mohammadi
Name of organization / entity
Mashhad Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3521 1135
Email address
mohammadikm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences Vice chancellor for research
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cold Application and Inhalation of Lavender Essential Oil on Pain and Anxiety during Chest Tube Removal in Cardiac Surgery Patients
Public title
The effect of cold and aromatherapy on reduce of pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion:
Subjects were of Iranian nationality.Willingness to participate.Upper 18 years old. Oriented to person, place and time.First time experience with cardiac surgery and chest tube removal.Lack of allergy to cold, plants and essential oils.Having chest tubes for 24 hours at least.
Exclusion:
Received mechanical ventilation support.Received Continuous infusion of sedatives and analgesics.Any difficulty breathing, nausea, vomiting oversensitivity and dissatisfaction during aromatherapy or cold application.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Ghoraishy Building, University St
City
mashhad
Postal code
Approval date
2014-10-25, 1393/08/03
Ethics committee reference number
930222
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before intervention, Immediately, 5 minutes, 10 minutes and 15 minutes after chest tube removal
Method of measurement
Visual Analog Scale
2
Description
Pain Quality
Timepoint
Before chest tube removal, Immediately after chest tube removal
Method of measurement
Modify Short Form McGill Pain Questionnaire
3
Description
Anxiety
Timepoint
Before chest tube removal, Immediately after chest tube removal
Method of measurement
Spielberger Situational Anxiety Questionnaire
Secondary outcomes
1
Description
Vital Sign
Timepoint
Before Intervention,Iimmediately after chest tube removal
Method of measurement
Monitoring
Intervention groups
1
Description
On the first postoperative morning, patients’ readiness for CTR was determined by a physician according to standard criteria.In cold therapy group, cooling gel packs were used to reduce the body temperature around the chest tube during undressing.when the skin temperature reached 13 °C, pack was removed and the nurse removed pericardial tube within 1-2 minutes.
Category
Other
2
Description
In Aromatherapy group, 1-2 drops of Lavender essence were poured on cotton was fixed at a 10 cm distance from the patients’ nose to Collar dress patient and the patient was asked to breathe slowly for 20 minutes and then pericardial tube removed within 1-2 minutes.
Category
Other
3
Description
In Cold & Aromatherapy group both intervention (cold gel packs application and inhalation of lavender essential oils for 20 minutes) was conducted.
Category
Other
4
Description
In control group, chest tube was removed as ward routine.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Narges mohammadi
Street address
Falahi 38/18- Ghasem Abad- Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Univesity of Medical Sciences
Full name of responsible person
Farzaneh Hasanzadeh
Street address
Nursing & Midwifery Faculty Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Univesity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medicsl Sciences
Full name of responsible person
Narges Mohammadi
Position
Msc- critical care nursing student
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty Mashhad
City
Mashhad
Postal code
Phone
+98 51 3521 1135
Fax
Email
mohammadin2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Univesity of Medical Sciences
Full name of responsible person
Farzaneh Hasanzadeh
Position
master degree
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
hasanzadehf@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medicsl Sciences
Full name of responsible person
Narges Mohammadi
Position
Msc- critical care nursing student
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
mohammadin2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)